EUCTR2016-000136-17-DE进行中（未招募）1 期
Prospective, randomized, multicenter clinical trial on the impact of Therapeutic Drug Monitoring (TDM) of piperacillin on organ functions and survival in the treatment of severe sepsis or septic shock - Target
Friedrich Schiller University Jena0 个研究点目标入组 276 人开始时间: 2016年4月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 276
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients with severe sepsis or septic shock
- •onset of severe sepsis or septic shock not longer than 24 hours prior to randomization
- •Antimicrobial therapy with piperacillin planned or started
- •age =18 years
- •written informed consent of the patient or legal representative
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 176
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •pregnant or breast-feeding women
- •anamnestic known hypersensitivity against beta-lactam antibiotics or another part of the investigational medicinal product
- •previous treatment with piperacillin (in combination with tazobactam) > 24 hours before randomization
- •participation in another interventional clinical trial
- •previous participation (TARGET)
- •limits of therapy or cessation
- •impaired liver function (Child-Pugh C)
- •life expectancy < 28 day due to accompanying illnesses
- •piperacillin-measurement impossible within 24 hours after randomization
研究者
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